2008 PMF Open Conference on Compendial Harmonization - "New Methods for Old" 

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SCHEDULE

The conference will be devoted to a discussion of the international regulatory climate with special emphasis on harmonized compendial chapters, and recently implemented chapters of the USP.  The conference will provide instruction and an opportunity for discussion of:

• The exploration of the continuum of the microbial control and test in the manufacture of sterile pharmaceutical products
• The determination of the inconsistencies in compendial, regulatory and industrial practices in microbial control (and the identification of how they could be made more consistent)
• The establishment of consensus positions whenever possible.

The afternoons of the conference will be devoted to discussion with compendial and regulatory experts on the following general topics:

• Aseptic Processing - USP <1211>, <1116> and the EU Annex 1 changes)
• Sterility Tests (USP <71>)
• Bacterial Endotoxin Tests (USP <85>)
• Harmonized Microbial Limits Chapters (<61>, <62>, and <1111>)
• Water Microbiology (USP <1231>)

Biographies for the speakers and discussion facilitators are available here.

Schedule